Aromatase Inhibitor Growth Study: Letrozole vs. Anastrozole

Short Stature Clinical Trial

Official title:

Randomization to Letrozole vs. Anastrozole in Short Pubertal Males

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02137538
• Other study ID #: AI growth study
• Status: Completed
• Phase: Phase 4
• Start date: November 18, 2009
• Est. completion date: June 5, 2018

Study information

• Verified date: June 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to determine if there are differences in the final height or hormone profile of short pubertal boys placed on different forms of aromatase inhibitor now routinely used to increase stature: Anastrozole and Letrozole. It also should determine if there are differences in the side effect profiles of the two drugs to be used.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: June 5, 2018
• Est. primary completion date: June 5, 2018
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 10 Years to 17 Years

Eligibility

Inclusion Criteria:

• Current height less than 5th percentile AND/OR
• Predicted adult height (based on bone age) more than 10 cm below target height (mid parental height)
• Evidence of puberty: physical signs and serum luteinizing hormone > 0.3 IU/L and testosterone > 15 ng/dl

Exclusion Criteria:

• Bone age reading more than 14.0 years
• Follicle stimulating hormone > 20 IU/L

Related Conditions & MeSH terms

• Dwarfism
• Short Stature

Intervention

Drug:
• Letrozole

• Anastrozole

Locations

Country	Name	City	State
United States	Lucile Packard Children's Hospital	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Neely EK, Kumar RB, Payne SL, Ranadive SA, Suchet DI. Letrozole vs anastrozole for height augmentation in short pubertal males: first year data. J Clin Endocrinol Metab. 2014 Nov;99(11):4086-93. doi: 10.1210/jc.2014-2432. Epub 2014 Aug 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predicted Adult Height at Year 3	Heights will be obtained by physical exam every 6 months during treatment. Skeletal maturation will be assessed from an x-ray by the method of Greulich and Pyle at baseline and every 12 months until the end of treatment.; Predicted adult height will be calculated at baseline and at the end of treatment based upon measured height and skeletal maturation (bone age).	Year 3
Secondary	Serum Testosterone		Baseline, year 3
Secondary	Dihydrotestosterone		Baseline, year 3
Secondary	Androstenedione		Baseline, year 3
Secondary	Luteinizing Hormone		Baseline, year 3
Secondary	Follicle Stimulating Hormone		Baseline, year 3
Secondary	Insulin-like Growth Factor Type 1		Baseline, year 3
Secondary	Inhibin B		Baseline, year 3
Secondary	Estradiol		Baseline, year 3
Secondary	Estrone		Baseline, year 3
Secondary	Number of Adverse Events Related to Acne or Bone Fracture		3 years